MAUDE Adverse Event Report: TORNIER S.A.S. 611 ANKLE FUSION NAIL

Model Number	NAIL RIGHT A6° D10 L180
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
During a surgery in order to remove a nail at the ankle, the surgeon notices that one of the screws locking the nail seems "welded".The surgeon was unable to perform the planned operation and had to perform a tibia osteotomy requiring an additional surgical approach as well as an increased duration of operation.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: 611 ANKLE FUSION NAIL
• Common Device Name: 611 ANKLE FUSION NAIL
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 8354126
• Report Number: 3000931034-2019-00030
• Device Sequence Number: 2288165
• Product Code: HSB
• UDI-Device Identifier: 03700386938276
• UDI-Public: 03700386938276
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: NAIL RIGHT A6° D10 L180
• Device Catalogue Number: LJU601
• Device Lot Number: 3400AN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other